The following data is part of a premarket notification filed by Chongqing Jinshan Science & Technology Co., Ltd. with the FDA for Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series.
Device ID | K210618 |
510k Number | K210618 |
Device Name: | Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series |
Classification | Endoscopic Irrigation/suction System |
Applicant | Chongqing Jinshan Science & Technology Co., Ltd. Yubei District No.18 Ningshang Avenue Jinshan International Industrial City Chongqing, CN 400000 |
Contact | Qing Xu |
Correspondent | Qing Xu Chongqing Jinshan Science & Technology Co., Ltd. Yubei District No.18 Ningshang Avenue Jinshan International Industrial City Chongqing, CN 400000 |
Product Code | OCX |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-03-01 |
Decision Date | 2021-10-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06946332803145 | K210618 | 000 |
06946332803749 | K210618 | 000 |
06946332803732 | K210618 | 000 |
06946332803718 | K210618 | 000 |